美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER 201692 003 ANDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML No Yes AP 2012/05/31 SANDOZ INC RX 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% 050636 001 NDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML No No 1989/12/22 ABRAXIS PHARM DISCN 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% 050635 001 NDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 900MG BASE/100ML Yes Yes 1989/12/22 ABRAXIS PHARM RX 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% 214401 001 ANDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML No No AP 2023/04/05 HIKMA RX 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% 214401 002 ANDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML No No AP 2023/04/05 HIKMA RX 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% 214401 003 ANDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML No No AP 2023/04/05 HIKMA RX 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER 065027 001 ANDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML No No 2001/06/29 ABBOTT LABS DISCN 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER 065027 002 ANDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML No No 2001/06/29 ABBOTT LABS DISCN 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER 065027 003 ANDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML No No 2001/06/29 ABBOTT LABS DISCN 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER 050648 001 NDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML No No 1989/12/29 BAXTER HLTHCARE DISCN 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER 050648 002 NDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML No No 1989/12/29 BAXTER HLTHCARE DISCN 详细信息
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER 050648 003 NDA CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 900MG BASE/100ML No No 1989/12/29 BAXTER HLTHCARE DISCN 详细信息
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER 020734 002 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;10GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER 020734 005 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;25GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER 020734 001 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;5GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER 020734 008 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;10GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER 020734 010 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;20GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER 020734 011 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;25GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER 020734 007 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;5GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER 020734 014 NDA AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 5%;10GM/100ML No No 1997/09/29 BAXTER HLTHCARE RX 详细信息
当前数据更新日期:2025年12月11日,更多信息请点击此处查询美国FDA药品数据库
数据库说明:本数据与美国FDA官方药品橙皮书数据库同步,在官方数据基础上,提供更全面的检索方式和更简洁高效、完整的数据展现,并且可以回溯专利及市场独占权(市场排他数据)历史信息。
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